510(k) K152833

Pruitt F3-S Polyurethane Carotid Shunt by LeMaitre Vascular, Inc. — Product Code MJN

K152833 is an FDA 510(k) premarket notification submitted by LeMaitre Vascular, Inc. for the device "Pruitt F3-S Polyurethane Carotid Shunt". The FDA issued a decision of Substantially Equivalent on January 21, 2016. The device falls under product code MJN (Catheter, Intravascular Occluding, Temporary), a Class II device regulated under 21 CFR 870.4450. LeMaitre Vascular, Inc. has at least 10 other 510(k) clearances on record.